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Evaluation of a Multi-Purpose Solution

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ClinicalTrials.gov Identifier: NCT00710879
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : February 8, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

Condition or disease Intervention/treatment Phase
Contact Lens Solutions Device: Bausch & Lomb Multi-Purpose Solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
Study Start Date : July 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Multipurpose Solution
Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
 Device: Bausch & Lomb Multi-Purpose Solution
Daily care for contact lenses.


Outcome Measures
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Primary Outcome Measures :
  1. Antimicrobial Efficacy [ Time Frame: 2 weeks, 3 months ]
    Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae


Secondary Outcome Measures :
  1. Solution Related AE's and Lens Changes [ Time Frame: 3 months, 6 months ]
    Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.

  2. Solution Utlility [ Time Frame: 3 months, 6 months ]
    The Utility was determined based on the results of the efficacy and safety evaluations.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
  • Must be able and willing to comply with all treatment and follow-up study procedures.
  • Must have a clear central cornea.
  • VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

  • Systemic disease affecting ocular health.
  • Using systemic or topical medications.
  • Wear monovision, multifocal or toric contact lenses.
  • Any grade 2 or greater slit lamp findings.
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710879


Locations
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United States, California
Dr. Nicholas Marsico
Torrance, California, United States, 90505
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Bev Barna Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00710879    
Other Study ID Numbers: 568
First Posted: July 8, 2008    Key Record Dates
Results First Posted: February 8, 2011
Last Update Posted: December 13, 2011
Last Verified: December 2011
Keywords provided by Bausch & Lomb Incorporated:
Efficacy